Created at Source Raw Value Validated value
June 25, 2024, noon usa

inclusion criteria: * healthy caucasian origin * male or female * age between 18 and 55 years * accepting not to participate in another covid-19 vaccine study until the end of the study * volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year * female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. * male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination * participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable * body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ecg should be normal/acceptable. * physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable * laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, albumin, glucose, creatinine, bun, uric acid, total bilirubin, direct and indirect bilirubin, lipid panel (total cholesterol, triglyceride, hdl, ldl), ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, leukocytes, platelet count, prothrombin time (pt) and activated partial thromboplastin time (aptt); hbsag, hiv-ab, hcv-ab; urine examination: urine color, appearance, specific gravity, ph, protein, glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if erythrocytes or leucocytes are out of the limits ) should be normal/acceptable. * antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. * drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates) * normal body weight in relation to height and age according to * bmi = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2) * informed consent given in written form according to section 15.3. * agree not to participate in another vaccine clinical trial until the end of the study. * agree to remain in the study area for the entire duration of the study.

inclusion criteria: * healthy caucasian origin * male or female * age between 18 and 55 years * accepting not to participate in another covid-19 vaccine study until the end of the study * volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year * female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile \[ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy\] or postmenopausal \[defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. * male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination * participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination * the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); * life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable * body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ecg should be normal/acceptable. * physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable * laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, albumin, glucose, creatinine, bun, uric acid, total bilirubin, direct and indirect bilirubin, lipid panel (total cholesterol, triglyceride, hdl, ldl), ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, leukocytes, platelet count, prothrombin time (pt) and activated partial thromboplastin time (aptt); hbsag, hiv-ab, hcv-ab; urine examination: urine color, appearance, specific gravity, ph, protein, glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if erythrocytes or leucocytes are out of the limits ) should be normal/acceptable. * antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. * drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates) * normal body weight in relation to height and age according to * bmi = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2) * informed consent given in written form according to section 15.3. * agree not to participate in another vaccine clinical trial until the end of the study. * agree to remain in the study area for the entire duration of the study.

April 10, 2021, 12:31 a.m. usa

inclusion criteria: - healthy caucasian origin - male or female - age between 18 and 55 years - accepting not to participate in another covid-19 vaccine study until the end of the study - volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year - female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. - male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination - participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination - the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); - life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable - body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ecg should be normal/acceptable. - physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable - laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, albumin, glucose, creatinine, bun, uric acid, total bilirubin, direct and indirect bilirubin, lipid panel (total cholesterol, triglyceride, hdl, ldl), ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, leukocytes, platelet count, prothrombin time (pt) and activated partial thromboplastin time (aptt); hbsag, hiv-ab, hcv-ab; urine examination: urine color, appearance, specific gravity, ph, protein, glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if erythrocytes or leucocytes are out of the limits ) should be normal/acceptable. - antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. - drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates) - normal body weight in relation to height and age according to - bmi = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2) - informed consent given in written form according to section 15.3. - agree not to participate in another vaccine clinical trial until the end of the study. - agree to remain in the study area for the entire duration of the study.

inclusion criteria: - healthy caucasian origin - male or female - age between 18 and 55 years - accepting not to participate in another covid-19 vaccine study until the end of the study - volunteers who do not plan to get a child in the next one year; the volunteer and the partner should use a reliable form of contraception (abstinence, condom, birth control implant, birth control pills used or iud used by the partner) during the study for at least 1 year - female participants of childbearing potential (defined as any female who has experienced menarche and who is not surgically sterile [ie, hysterectomy, bilateral tubal ligation, or bilateral oophorectomy] or postmenopausal [defined as amenorrhea at least 12 consecutive months) must agree to be heterosexually inactive through 12 months after the first vaccination or agree to consistently use any of the described methods of contraception from through 12 months after the first vaccination. - male subjects agree to refrain from sperm donation from the time of first vaccination until 3 months after last vaccination - participants must refrain from blood or plasma donation from the time of first vaccination until 3 months after last vaccination - the outcome of the following examinations should be clinically insignificant: medical and surgical history (hypo-, hypertension, allergy, other diseases, major surgery, micturition, defecation, sleep, illness within the last 4 weeks prior to the start of the trial); - life style and habits (consumption of alcohol, nicotine, coffee, tea, coke, special diet, drug abuse) should be normal/acceptable - body temperature, pulse rate, blood pressure, respiratory rate and 12 lead ecg should be normal/acceptable. - physical examination (general state and abnormal findings per system: endocrine/metabolic, allergies, drug sensitivities, head, neck, eyes, ears, nose, throat, cardiovascular, respiratory, gastrointestinal, hepatic/biliary, urogenital, musculoskeletal, lymph nodes, skin, and neurological/psychiatric) should be normal/acceptable - laboratory examination (blood/serum examination: sodium, potassium, calcium, chloride, total protein, albumin, glucose, creatinine, bun, uric acid, total bilirubin, direct and indirect bilirubin, lipid panel (total cholesterol, triglyceride, hdl, ldl), ast, alt, ggt, alp, haemoglobin, haematocrit, erythrocytes, leukocytes, platelet count, prothrombin time (pt) and activated partial thromboplastin time (aptt); hbsag, hiv-ab, hcv-ab; urine examination: urine color, appearance, specific gravity, ph, protein, glucose, ketones, blood, leukocytes, bilirubin, urobilinogen, nitrites and sediment if erythrocytes or leucocytes are out of the limits ) should be normal/acceptable. - antisars cov 2 total antibody (including covid-19 igg and/or igm) negative in serum. - drug screening negative (amphetamines, cannabinoids, benzodiazepines, cocaine, opioids, barbiturates) - normal body weight in relation to height and age according to - bmi = weight(kg) / height (m)2 (accepted range 18.5 and 30 kg/m2) - informed consent given in written form according to section 15.3. - agree not to participate in another vaccine clinical trial until the end of the study. - agree to remain in the study area for the entire duration of the study.